# K050200: Magnetom Trio a Tim System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 28, 2005 after 31 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971684 (1997). 4 ancestors in all.
428 later devices descend from it; 7 cite it directly.
22 of 433 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032428: Magnetom Avanto MR System, Siemens Medical Solutions USA, Inc. (2003) Summary page 2.
- K013586: Magnetom Trio System, Siemens Medical Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K052164: Magnetom Systems with Software Syngo MR 2006A (2005), 312 descendants of its own
- K062454: Magnetom Systems - I-Class and T-Class Releases (2006), 308 descendants of its own
- K072237: Magnetom Verio (2007), 300 descendants of its own
- K082427: Syngo MR B17 (2008), 229 descendants of its own
- K071925: Magnetom Essenza (2007), 228 descendants of its own

## Recalls of this device
- Mar 3, 2011 · Not classified · Z-2021-2011: Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to beco
- Oct 12, 2006 · Not classified · Z-0225-2007: Possible excessive RF exposure/may burn
- Oct 12, 2006 · Not classified · Z-0226-2007: Possible excessive RF exposure/may burn

## Indications for use
The MAGNETOM Trio a Tim System is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Source page: https://510kreport.com/device/K050200
Methodology: https://510kreport.com/methodology